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DiamiR Biosciences and Aptorum Group Announce New York State Approval for DiamiR’s APOE Genotyping Test
NEW YORK, NY, NEW HAVEN, CT, and PRINCETON, N.J., Aug. 21, 2025 (GLOBE NEWSWIRE) -- DiamiR Biosciences Corp. (“DiamiR”), a developer of innovative blood-based diagnostic tests for brain health and other diseases, and Aptorum Group Limited (NASDAQ: APM) ("Aptorum Group” or “Aptorum”), a clinical stage biopharmaceutical company dedicated to addressing unmet medical needs, today announced that DiamiR received a Clinical Laboratory Evaluation Program (CLEP) Test Approval for its APOE Genotyping test
About this update from Aptorum Group Limited
[{"type":"text","content":"NEW YORK, NY, NEW HAVEN, CT, and PRINCETON, N.J., Aug. 21, 2025 (GLOBE NEWSWIRE) -- DiamiR Biosciences Corp. (“DiamiR”), a developer of innovative blood-based diagnostic tests for brain health and other diseases, and Aptorum Group Limited (NASDAQ: APM) ("Aptorum Group” or “Aptorum”), a clinical stage biopharmaceutical company dedicated to addressing unmet medical needs, today announced that DiamiR received a Clinical Laboratory Evaluation Program (CLEP) Test Approval for its APOE Genotyping test from the New York State Department of Health (NYSDOH). This milestone allows DiamiR to offer its validated APOE Genotyping molecular testing in a variety of biological samples, such as blood, buccal swab, saliva, and tissue, through its Clinical Laboratory Improvement Amendments (CLIA) certified, College of American Pathologists (CAP) accredited clinical laboratory by licensed healthcare providers in New York State and nationwide.","length":940,"tagName":"p"},{"type":"text","content":"New York State DOH CLEP is known for having stringent validation standards for laboratory-developed tests (LDTs). Clinical laboratories testing biospecimens from New York residents must obtain a clinical laboratory permit from NYSDOH to help ensure the accuracy and reliability of clinical tests.","length":296,"tagName":"p"},{"type":"text","content":"“We are very pleased to have received approval from the NYSDOH for our APOE genotyping test and excited about achieving this regulatory milestone as we continue to build our portfolio of molecular tests for brain health, including neurodegenerative diseases such as mild cognitive impairment and Alzheimer’s disease,” said Alidad Mireskandari, Ph.D., CEO of DiamiR Biosciences. “This milestone expands access to an important tool that can help inform risk assessment, clinical trial enrollment, and personalized care strategies for individuals at risk of cognitive decline.”","length":574,"tagName":"p"},{"type":"text","content":"About APOE Testing","length":18,"tagName":"p"},{"type":"text","content":"The APOE test identifies genetic variants associated with risk for late-onset Alzheimer’s disease and other neurological conditions. The APOE gene exists in three common variants (ε2, ε3, and ε4), with the APOE ε4 allele being the strongest known genetic risk factor for late-onset Alzheimer's disease. Individuals ...